Sterilmed Inc
Plymouth, MN, US
STERILMED, INC. appears in FDA device records in Plymouth, MN. FDA records list 65 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 41 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 65FDA records hold 65 510(k) clearances for Sterilmed Inc between 2001 and 2026. The busiest year on record is 2002, with 9. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 8 |
| 2002 | 9 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 7 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 4 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 5 |
| 2019 | 3 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | OWQ | Substantially Equivalent | |
| K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | NLH | Substantially Equivalent | |
| K190478 | Reprocessed ViewFlex™ Xtra ICE Catheter | OWQ | Substantially Equivalent | |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | NLQ | Substantially Equivalent | |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | NLQ | Substantially Equivalent | |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | OWQ | Substantially Equivalent | |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) | NUJ | Substantially Equivalent | |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | NLH | Substantially Equivalent | |
| K152090 | Reprocessed Steerable Introducer | PNE | Substantially Equivalent | |
| K152134 | Reprocessed Vessel Sealer | NUJ | Substantially Equivalent | |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | NLH | Substantially Equivalent | |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | NLQ | Substantially Equivalent | |
| K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider | NUJ | Substantially Equivalent | |
| K132566 | REPROCESSED HARMONIC SHEAR | NLQ | Substantially Equivalent | |
| K133414 | REPROCESSED CLOSURE SYSTEM | NLM | Substantially Equivalent | |
| K123096 | REPROCESSED VESSEL SEALER | NUJ | Substantially Equivalent | |
| K120040 | REPROCESSED SURGICAL ELECTRIC INSTRUMENT | NUJ | Substantially Equivalent | |
| K121158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | |
| K121240 | REPROCESSED ENDOSCOPIC TROCARS | NLM | Substantially Equivalent | |
| K120204 | REPROCESSED FEMORAL COMPRESSION DEVICE | NMF | Substantially Equivalent | |
| K111794 | REPROCESSED HARMONIC SCALPEL | NLQ | Substantially Equivalent | |
| K110076 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER | OWQ | Substantially Equivalent | |
| K111002 | REPROCESSED ENDOSCOPIC TROCARS | NLM | Substantially Equivalent | |
| K102560 | REPROCESSED PULSE OXIMETER SENSORS | NLF | Substantially Equivalent | |
| K101789 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | |
| K100707 | REPROCESSED PINS | NDM | Substantially Equivalent | |
| K092158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | |
| K092368 | REPROCESSED PULSE OXIMETER SENSORS | NLF | Substantially Equivalent | |
| K083636 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | |
| K083060 | REPROCESSED HARMONIC SCALPEL | NLQ | Substantially Equivalent | |
| K081814 | REPROCESSED ENT SHAVERS | ERL | Substantially Equivalent | |
| K081586 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | |
| K081342 | REPROCESSED EXTERNAL FIXATION ACCESSORIES | KTT | Substantially Equivalent | |
| K073613 | REPROCESSED SCISSOR TIPS | NUJ | Substantially Equivalent | |
| K070930 | REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS | NLL | Substantially Equivalent | |
| K070859 | REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS | NLL | Substantially Equivalent | |
| K063844 | REPROCESSED HEART STABILIZERS AND POSITIONERS | NQG | Substantially Equivalent | |
| K052299 | REPROCESSED ENDOSCOPIC TROCAR | NLM | Substantially Equivalent | |
| K053188 | REPROCESSED BALOON INFLATION DEVICE | NKU | Substantially Equivalent | |
| K050136 | REPROCESSED HOT BIOPSY FORCEPS | NLU | Substantially Equivalent | |
| K042648 | REPROCESSED COLD BIOPSY FORCEPS | NON | Substantially Equivalent | |
| K051220 | REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | |
| K043592 | REPROCESSED ENDOSCOPIC TROCAR | NLM | Substantially Equivalent | |
| K050343 | REPROCESSED HARMONIC SCALPELS | NLQ | Substantially Equivalent | |
| K043513 | STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER | NLH | Substantially Equivalent | |
| K043453 | STERILEMED REPROCESSED IVUS IMAGING CATHETER | OWQ | Substantially Equivalent | |
| K041127 | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | NLF | Substantially Equivalent | |
| K012677 | REPROCESSED PULSE OXIMETER SENSORS | NLF | Substantially Equivalent | |
| K012537 | REPROCESSED IMAGING CATHETERS | OWQ | Substantially Equivalent | |
| K012678 | REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011276773 | 3011276773 | STERILMED, INC. | 5010 Cheshire Pkwy N Ste 2, Plymouth, MN 55446 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HRXArthroscope
- NMLCatheter, Biliary, Reprocessed
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- MTDCatheter, Intracardiac Mapping, High-Density Array
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed
- NLHCatheter, Recording, Electrode, Reprocessed
- NMFClamp, Vascular, Reprocessed
- FFLDislodger, Stone, Basket, Ureteral, Metal
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- JOSElectrode, Electrosurgical
- NLWElectrode, Electrosurgical, Active, Urological, Reprocessed
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- NLUForceps, Biopsy, Electric, Reprocessed
- NONForceps, Biopsy, Non-Electric, Reprocessed
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed
- NLMLaparoscope, General & Plastic Surgery, Reprocessed
- NKXNeedle, Phacoemulsification, Reprocessed
- NLFOximeter, Reprocessed
- NDMPin, Fixation, Threaded, Metallic
- GEXPowered Laser Surgical Instrument
- QNWReprocessed Bronchoscope
- PNEReprocessed Catheter Introducer
- OWQReprocessed Intravascular Ultrasound Catheter
- NLQSingle-Use Reprocessed Ultrasonic Surgical Instruments
- JOWSleeve, Limb, Compressible
- OSNSoftware For Diagnosis/Treatment
- NQGStabilizer, Heart, Non-Compression, Reprocessed
- NLLStaple, Implantable, Reprocessed
Recall records
Showing 25 of 41| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0574-2026 | Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism. | Class II | Open, Classified | |
| Z-0573-2026 | Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism. | Class II | Open, Classified | |
| Z-0090-2019 | Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324 | Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. | Class II | Terminated | |
| Z-0213-2018 | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. | Inadequate seal due to lack of adhesive glue | Class I | Terminated | |
| Z-2669-2017 | Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment. | Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval. | Class II | Terminated | |
| Z-1846-2016 | Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162. | Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury. | Class II | Terminated | |
| Z-0404-2016 | Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only. | Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue. | Class II | Terminated | |
| Z-2819-2015 | Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices. | Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices. | Class II | Terminated | |
| Z-0059-2015 | Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. | Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne | Class II | Terminated | |
| Z-0577-2009 | Reamers Model #'s: HAL5091-144 and ZIMS5979-95-41 An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0576-2009 | Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0575-2009 | Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC1536 MIC1589 MIC1597 MIC1598 and MIC1599 The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0574-2009 | Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suites, in which for whatever reason the physician elected to select a different type of device, different size of device, or maybe elected to not use the device at all in a procedure. This is not a process regulated by FDA, but is included in the recall process as product would still be considered misbranded and or represent a potential risk to patients. Model #'s: ABB6543-01 ABB6544-01 ACM23116 ACR800-499 ACU014719 ALL2N2704X ALLASC1201 ALLF-5501 ALLSU130-404E ARTAR-6530 ARTAR-6540 ARTAR-6560 ARTAR-6562 ARTAR-6564 ARTAR-6570 AUT054887 AUT059035 AUT059037 AUT174001 AUT8886803712 AUTGIA6025S BAL60417 BAR0043620 BAR0070740 BAR0601110 BAR072231 BARBRD100R BAX2C4005 BER610 BIO418200 BIO631031 BOUTC001NSKA CARASU1510 COD26-1221 CON130309 CON130321 CON134006 CON1412 CON29410 CON29415H CON29496 CON60-6085-100 CON8535 CON9413 CON9448 COO081012 COO081014 COOCTI-512N COOTD-1 COOZSI1151 DAV0035280 DAV0043650 DEN50-7000 DEN50-7500 DER28-0211 DLP10012 EDWDSAFE61 EDWFEMII016A ETH10BB ETH2189 ETH2211 ETH5BB ETH6TB45 ETHBTD05 ETHPMW35 ETHPRW35 ETHPXW35 ETHUV120 FUT4549 GUIOM-9000S GUIXP-4000 GYR240060 GYR240072 GYR70138000 GYR7013-8100 GYR70140257 JOH2214 KEN31140240 KEN31140562 KEN8884720221 KEN8888505172 KIM111 KIM228 kim279 KIM311 KIM330 KIM345 KIM70321 KIM79043 KIM79870 KIM79878 KIM888 KIM89601 KIM95111 KIM95521 KIR10-4000 KIR10-4001 KIR14-3000 KRO6003 LIN9718 LINESA-5333 LINESA-5339 MECEPT03 MED05897/JP2311 MED10001S/JP10001 MED11348/DYNJP2500 MED14184/JP2414 MED14184A/JP2414A MED21394P/JP2302P MED2457S/JP8303 MED2505/JP2510 MED3110A/JP3003A MED3110S/JP3003 MED3130S/JP3008 MED3140S/JP3005 MED3820A/JP3102A MED3820S/JP3102 MED4202S/JP4003 MED6052-53 MED8610S/JP8005 MED91263 MED96570-021 MEDDYNJ01201H MEDDYNJ05933 MEDDYNJO5933 MEDDYNJP8201 MEDSPT-2314/JP2314HD MEG0012 MEG0020 MEG0035H MEG0039H MIC390-310 MIC6131 MIC6237 MIC670-308 MIC710-111 MIC81010 MPS5001689 OLS20-1410KI ORSORS-300 Q2M20-1370 RMITF-3646-0 SMI4116 SMI4615 SMI4616 SMI71111579 SMI7204727 SMI72200195 SPIXDWIK28 STR1608-2-59 STR1608-2-63 STR206-16 STR206-546 STR250-070-530 STR250-070-540 STR275-802-000 STR306-553 STR350-202-000 STR3910-075-500 STR3910-075-501 STR3910-075-650 STR3910-075-651 STR3910-075-800 STR400-800 STR501-140-50 STR5120-103-15 STR606-563 STR620-030-301 STR620-030-407 STR620-30-301 SYN55.36E SYNSDLB TELDP-40K TELMDP-40K TER5842 TERL7328 TEX311033-000 USE00712031 VALE1450-6 VALE1510 VALE2350H VALE2450H VALE2505-10FR VALE2515H VALE2516H WAL909009 WEC528235 WEL24-6001 XOM1014242 XOM10-46001 XOM1850200 XOM31-55631 XOM31-55632 XOM31-55636 XOM31-55637 XOM31-55638 and XOM8225825 | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0573-2009 | TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G and STO27050NK Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection for soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0572-2009 | Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-235 STR5921-024-135 STR5921-024-136 STR5921-024-146 STR5921-024-235 STR5921-030-135 STR5921-030-235 STR5921-034-135 STR5921-034-136 STR5921-034-235 STR5921-044-135 STR5921-044-136 STR5921-044-235 STR5921-212-135 ZIM60-7070-02 ZIM60-7070-03 ZIM60-7070-04 ZIM60-7070-05 ZIM60-7070-06 ZIM60-7070-07 ZIM60-7070-101 ZIM60-7070-102 ZIM60-7070-103 ZIM60-7070-104 ZIM60-7070-105 ZIM60-7070-106 ZIM60-7070-107 ZIM60-7075-006 ZIM60-7075-03 ZIM60-7075-04 ZIM60-7075-05 ZIM60-7075-06 ZIM60-7075-07 ZIM60-7075-101 ZIM60-7075-102 ZIM60-7075-103 ZIM60-7075-104 ZIM60-7075-106 ZIM60-7075-107 ZIM60-7080-102 and ZIM60-7080-103 A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0571-2009 | Stone Retrieval Basket Model #': BOS390-105 Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0570-2009 | Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89-5100 and SNO89-5300 Intended to be used with a resusable hand piece and are designed to use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting tissue. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0569-2009 | Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118 HAL5059-32 HAL5071-133 HAL5071-145 HAL5071-163 HAL5071-181 HAL5071-572 HOWHB-NST-6828-7-791 HOWHB-NST-6828-7-792 KOMK-2000-65 KOMKM-004 KOMKM-005 KOMKM-101 KOMKM-101C KOMKM-102 KOMKM-234 KOMKM-275R KOMKM-3101 KOMKM-3107 KOMKM3-225 KOMKM-325R KOMKM-619 KOMKM-660 KOMKM-693 LIN5023-170 MICSO-601 MICSO-610 MICSP-414A MICZO-062 MICZO-7052 MMM5756 STR2108-100 STR2108-102 STR2108-105 STR2108-107-4 STR2108-109 STR2108-110 STR2108-113 STR2108-115 STR2108-118 STR2108-120 STR2108-125 STR2108-140 STR2108-140-6 STR2108-148 STR2108-150 STR2108-150S2 STR2108-151 STR2108-152 STR2108-152-6 STR2108-158 STR2108-160 STR2108-161-2 STR2108-183 STR2108-185 STR2108-189 STR2108-192 STR2108-218 STR2108-302 STR2108-309 STR2108-351 STR2108-356 STR2296-3-103 STR2296-3-105 STR2296-3-111 STR2296-3-115 STR2296-3-125 STR2296-3-212 STR2296-3-225 STR2296-33-105 STR2296-33-111 STR2296-33-125 STR2296-3-412 STR2296-3-414 STR2296-3-511 STR277-88-100 STR277-88-125 STR277-96-250 STR277-96-275 STR277-96-277 STR277-96-325 STR277-96-326 STR298-97-100 STR4111-107-090 STR4125-089-075 STR4125-097-090 STR5100-137-233 STR5301-30-172 STR5301-40-33 STR6113-127-90 STR6125-89-75 SYN11-2217 SYN11-3500 SYN11-3534 TER98-0702-1234-9 ZIM5979-95-35 and ZIM5979-95-41 Surgical instruments motors and accessories are AC-powered, battery-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0568-2009 | RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01 ARTA2630-01 ARTA3625-01 ARTA4330-01 ARTAS1335-01 ARTAS4630-01 ARTASC1335-01 ARTASC2530-01 ARTASC4250-01 ARTASC4830-01 ARTASC5000-01 ARTASC5500-01 ARTEIC4845-01 MIT225203 MIT225301 MIT225302 MIT225305 MIT225350 MIT225360 SMI7209681 SMI7209682 SMI7209683 and STR278-510-500 These devices are designed for general surgical use, including orthopedic and arthroscopic applications or resection, ablation, excision of soft tissue, hemostatis of blood vessels, and coagulation of soft tissue. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0567-2009 | Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0566-2009 | Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0565-2009 | Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC8065750852 ALC8065790020 ALC8065790022 and ALLOPOR3020L Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0564-2009 | Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625 AUT176657 AUTPTACK30 ETHEL5ML ETHER320 ETHMCL20 ETHMCM20 ETHMCM30 ETHMCS20 ETHMSM20 and WEC543965 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0563-2009 | Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140 An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated | ||
| Z-0562-2009 | Laser Probe Model #': SYN55.26.25 Reprocessed laser probes are part of a laser delivery system and are used in opthalmic procedures where laser energy is the mode of treatment. | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Sterilmed Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain